Sociocultural Influences on Pain Assessment

Overseen By Lauren Y Atlas, Ph.D.

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: National Center for Complementary and Integrative Health (NCCIH)

Must not be taking: Opiates, Antidepressants, Anticonvulsants, others

Disqualifiers: Neurological conditions, Mood disorders, Chronic pain, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

700 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how social and cultural factors affect pain perception and assessment, focusing on health disparities among different groups. By examining pain responses and judgments in various settings, researchers aim to identify biases and improve pain assessment accuracy. Participants will encounter different pain stimuli, such as cold water (cold water bath) or mild shocks (electric shock stimulator), and their reactions will be observed. Healthy individuals without chronic pain, certain medical conditions, or left-handedness are suitable for this trial. The goal is to understand and address discrepancies in pain management across diverse populations. As an unphased trial, this study offers participants a unique opportunity to contribute to research that could lead to more equitable pain management practices.

Do I need to stop taking my current medications for this trial?

Yes, if you regularly use prescription medications that significantly affect pain or heat perception, such as opiates, antidepressants, anticonvulsants, anxiolytics, hypnotics, antipsychotics, antimigraine agents, and muscle relaxants, you will need to stop taking them. However, using non-prescription pain relievers like ibuprofen or acetaminophen occasionally is allowed, as long as the last dose was not taken within 5 half-lives of testing.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that cold water baths and ice baths can reduce muscle soreness and swelling. Some studies suggest they might also boost mood and thinking skills. However, experts caution that sudden exposure to cold water can be risky, especially for certain individuals.

Detailed safety information for the electric shock stimulator is not available. If tested in an early trial, there might be limited safety data.

The Medoc thermal stimulator is a non-invasive device used to study pain. The FDA has approved it for measuring how nerves react to temperature changes, indicating it has been tested for safety and is commonly used in pain research.

These treatments have been studied before, providing some insight into their safety. However, as each body is different, it is important to consider the benefits and risks before deciding to join a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how sociocultural factors influence the way we assess pain. Unlike traditional methods that primarily focus on biological aspects, this study considers how cultural contexts and feedback can affect pain perception and judgment. By using innovative tools like cold water baths, electric shocks, and thermal stimulators, the trial aims to deepen our understanding of pain assessment accuracy across different social settings. This could revolutionize how we approach pain management, leading to more personalized and effective treatment plans in the future.

What evidence suggests that this trial's treatments could be effective for addressing health disparities in pain?

Research has shown that cold water immersion can ease muscle soreness after exercise and might boost overall well-being by reducing inflammation and stress over time. In this trial, the cold water bath is one of the treatments under study. Another treatment is the electric shock stimulator, which studies indicate can effectively manage different types of pain by altering pain perception. Additionally, the Medoc thermal stimulator is used to control and study reactions to heat-related pain, aiding in understanding pain limits and tolerance. This trial examines how social factors might influence pain assessment, aiming to reduce biases. ^{1 4 6 7 8}

Who Is on the Research Team?

Lauren Y Atlas, Ph.D.

Principal Investigator

National Center for Complementary and Integrative Health (NCCIH)

Are You a Good Fit for This Trial?

Healthy adults aged 18-60 who speak English fluently and can consent to participate are eligible for this study. Excluded are those with chronic pain conditions, certain medical issues affecting sensation or pain perception, employees of NCCIH and NIMH, non-US residents, and individuals taking specific prescription medications.

Inclusion Criteria

All Sub-Studies: Healthy

All Sub-Studies: Able to provide written informed consent

All Sub-Studies: Fluent in English

Exclusion Criteria

I have scars, burns, or a recent tattoo in the test area that could affect skin sensitivity.

I don't regularly use meds that affect pain or heat feeling, except for occasional painkillers.

All Sub-Studies: Has a major-medical condition or medical history that in a clinician's assessment could affect ability to comply with study procedures, including neurological or psychiatric conditions (including stroke and blindness or deafness, a history of brain damage, substance or alcohol dependence or abuse or psychosis)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Assessment

Measure pain perception and physiological responses to painful stimuli in a diverse group of individuals

4-6 weeks

Multiple visits (in-person)

Perception Study

New participants view images of initial participants and provide estimates of their pain experience

4-6 weeks

Multiple visits (in-person)

Feedback and Training

Participants receive feedback on their performance to improve accuracy in pain assessment

4-6 weeks

Multiple visits (in-person)

Follow-up

Participants are monitored for accuracy and biases in pain assessment after interventions

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cold water bath
• Electric shock stimulator
• Medoc thermal stimulator
• Pain assessment performance feedback

Trial Overview The trial investigates how social and cultural factors influence the experience of pain and its assessment by others. It involves electric shocks, thermal stimulation via a thermode device, cold water immersion tests, facial expression recording during painful stimuli, heart activity monitoring, sweat measurement sensors on the hand, facial muscle electrical activity testing through electrodes attached to the skin.

How Is the Trial Designed?

Group I: Substudy 3: Feedback Group Experimental Treatment 1 Intervention

Participants in substudy 3's Feedback Group will be informed about their performance after every trial when making judgments about other people's pain.

Group II: Substudy 1: All participants Experimental Treatment 3 Interventions

Measuring facial response to painful stimulation.

Group III: Substudy 2: Healthy volunteers Active Control 1 Intervention

Measuring pain assessment accuracy

Group IV: Substudy 3: Control Active Control 1 Intervention

Subjects will judge stimuli with the same instructions as Sub-Study 2 (which provides a test of replication).

Who Is Running the Clinical Trial?

National Center for Complementary and Integrative Health (NCCIH)

Lead Sponsor

Trials

886

Recruited

677,000+

Published Research Related to This Trial

Heat is the most commonly used method to induce pain in both animals and humans, allowing researchers to study pain mechanisms and the effects of various treatments.

Different techniques, including contact heat and various types of lasers, are employed to evoke heat pain, which can lead to the development of new methods for pain research and clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lasers and other thermal stimulators for activation of skin nociceptors in humans. Arendt-Nielsen, L., Chen, AC.[2019]

A study involving 20 healthy young men found that alternating heat and cold stimulation, particularly at a 3:1 ratio, significantly reduced trapezius muscle hardness and subjective muscle stiffness after typing tasks.

The 3:1 heat-to-cold ratio was the most effective condition, showing improvements in muscle hardness compared to no stimulation, although changes in muscle hardness did not directly correlate with subjective symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of alternating heat and cold stimulation at different cooling rates using a wearable thermo device on shoulder muscle stiffness: a cross-over study. Sawada, T., Okawara, H., Nakashima, D., et al.[2022]

External electrical stimulation effectively controls acute pain in approximately 80% of patients, making it a promising option for immediate pain relief.

For chronic pain, however, only about 25% of patients experience significant relief from this method, suggesting the need for a more comprehensive treatment approach that includes therapies like operant conditioning and physical exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The viability of external electrical stimulation as a therapeutic modality. Shealy, CN.[2011]

In a study involving 15 subjects, intramuscular injections of warm and cold isotonic saline did not elicit any thermal sensations, even though similar temperatures applied to the skin produced strong sensations.

However, injections of isotonic saline at 48 degrees C did cause muscle pain, suggesting that high-threshold warm-sensitive receptors may mediate pain rather than thermal sensations in muscle.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thermosensitivity of muscle: high-intensity thermal stimulation of muscle tissue induces muscle pain in humans. Graven-Nielsen, T., Arendt-Nielsen, L., Mense, S.[2022]

The thermal stimulation system can precisely control skin temperature between 30 to 60 degrees Celsius and heat it rapidly, making it useful for studying temperature sensation in various scientific fields.

Safety features are integrated to prevent accidental burns, ensuring the system can be used safely during experiments, including those involving electrophysiological recordings without electronic interference.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A contact thermal stimulator for neurobehavioral research on temperature sensation. Morrow, TJ., Casey, KL.[2019]

Superficial heating and cooling techniques have been shown to effectively relieve low to moderate pain in children, similar to their use in adults, but standardized guidelines were lacking in UK children's centers before this project.

After three years of implementing new protocols and educational support for these pain relief methods, an audit confirmed their benefits, highlighting their role in providing cost-effective and holistic care for pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Managing pain using heat and cold therapy. Lane, E., Latham, T.[2019]

Transcutaneous electrical stimulation is a widely accepted method for managing various types of pain, including chronic and acute pain, demonstrating its efficacy as a therapeutic option.

Implantable peripheral nerve stimulators have shown the highest effectiveness for treating pain related to peripheral nerve injuries, although their effectiveness for pain outside the stimulated nerve's distribution remains unproven.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrical stimulation for the control of pain. Long, DM.[2019]

Electrotherapy has evolved from ancient methods using electric fish to modern techniques like TENS and spinal cord stimulation, which are effective for treating various types of pain, including mild to moderate pain and refractory neuropathic pain.

Recent studies have shown that electrical stimulation not only relieves pain but also helps prevent or treat muscle dysfunction and sarcopenia in patients with chronic conditions, highlighting its dual role in pain management and muscle health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromuscular electrostimulation techniques: historical aspects and current possibilities in treatment of pain and muscle waisting. Heidland, A., Fazeli, G., Klassen, A., et al.[2022]

Transcutaneous electrical stimulation (TNS) can effectively produce local analgesia for chronic pain, but its effectiveness relies on perceptible stimulation and localized paresthesias in the painful area.

In a study with healthy subjects, TNS using small rectangular pulses at a frequency of 100 Hz demonstrated the best analgesic effects, suggesting that the mechanism involves spinal level mechanisms and possibly longer neural pathways.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

TNS-evoked long loop effects. Hiedl, P., Struppler, A., Gessler, M.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5285720/

The effects of cold water immersion and active recovery on ... Our results suggest that cold water immersion is no more effective than active recovery for minimizing the inflammatory and stress responses in muscle after ...

2. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0317615

Effects of cold-water immersion on health and wellbeing This systematic review suggests that CWI delivers time-dependent effects on inflammation, stress, immunity, sleep quality, and quality of life.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6492480/

Cold‐water immersion (cryotherapy) for preventing and ... There was some evidence that cold‐water immersion reduces muscle soreness at 24, 48, 72 and even at 96 hours after exercise compared with 'passive' treatment.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06667193

Cold Water Exposure's Effects on Physical and Mental Health The investigators hypothesize measures relating to mental performance and health will improve after 4-weeks of CWI, and there will be no difference between tub ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2666061X25000690

Thermal Modalities Including Hot Baths and Cold Plunges ... Cold therapy was seen to decrease delayed-onset muscle soreness and help resolve global or generalized muscle injury or fatigue. In sum, both cold and hot ...

6. medicalnewstoday.com medicalnewstoday.com/articles/ice-bath-benefits

Ice bath benefits, risks, and safety explained Ice baths may have several health benefits, including helping to reduce muscle pain and inflammation and improving mood and cognitive ability.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9518606/

Health effects of voluntary exposure to cold water Some of the studies indicate that voluntary exposure to cold water has some beneficial health effects.

8. heart.org heart.org/en/news/2022/12/09/youre-not-a-polar-bear-the-plunge-into-cold-water-comes-with-risks

You're not a polar bear: The plunge into cold water comes ... Experts caution that for some people, shocking the body with cold water could do more harm than good, even at less-than-frigid temperatures. The ...